Myelodysplastic Syndrome Clinical Trial

A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

Summary

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants:

Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept
Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met
The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase
Transition Phase is defined as one Enrollment visit
Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol

Follow-up Phase includes:

- 42 Day Safety Follow-up Visit

During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting

- Long-term Post-treatment Follow-up (LTPTFU) Phase

Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule

Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study.

The rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill at least 5 years from the first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must meet all the following criteria to be enrolled in this study:

Participant is ≥ 18 years at the time of signing the informed consent form (ICF).
Participant is willing and able to adhere to the study visit schedule and other protocol requirements.

Participant has been participating in a luspatercept trial and continues to fulfill all the requirements of the parent protocol and the participant has been either:

Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and should continue to receive luspatercept treatment, OR
Assigned to placebo arm in the parent protocol (at the time of unblinding or in follow-up) and should cross over to luspatercept treatment, OR
Assigned to the Follow-up Phase of the parent protocol, previously treated with luspatercept or placebo in the parent protocol who shall continue into Long-term Post-treatment Follow-up Phase in the rollover study until the follow-up commitments are met (unless requirements are met as per parent protocol to crossover to luspatercept treatment).
Participant understands and voluntarily signs an informed consent document prior to any study-related assessments or procedures being conducted.
Participant demonstrates compliance, as assessed by the investigator, with the parent study protocol requirements.
Applies to on treatment Participants only- females of childbearing potential (FCBP) defined as a sexually mature woman who:

1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or amenorrhea due to other medical reasons does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) and must:

Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the participant practices true abstinence* from heterosexual contact.

Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with highly effective, contraception without interruption, 35 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 84 days after discontinuation of study therapy.

7. Applies to on treatment participants only- Male participants must:

a. Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 84 days following investigational product discontinuation even if he has undergone a successful vasectomy.

Exclusion Criteria:

The presence of any of the following will exclude a participant from enrollment:

Applies to on treatment participants only- Concomitant use of any medications/procedures that are prohibited in the parent luspatercept protocol.
Participant has met one or more criteria for study discontinuation as stipulated in the parent luspatercept protocol.
Applies to on treatment participants only- More than 26 days between last luspatercept dose in the parent protocol and first dose into ACE-536-LTFU-001 protocol unless dose delay or dose discontinuation criteria met.
Applies to on treatment participants only- Pregnant or breastfeeding females.
Participant has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (eg, imprisoned or institutionalized) that would prevent the subject from participating in the study.
Participant has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
Participant has any condition that confounds the ability to interpret data from the study.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

665

Study ID:

NCT04064060

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 124 Locations for this study

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Childrens Hospital Los Angeles RHU
Los Angeles California, 90027, United States
Childrens Hospital Los Angeles RHU
Los Angeles California, 90027, United States More Info
Thomas Coates, Site 968
Contact
323-361-2352
Local Institution - 971
Oakland California, 94609, United States
UCSF Benioff Children's Hospital Oakland
Oakland California, 94609, United States
Local Institution - 978
Stanford California, 94305, United States
Stanford Cancer Center
Stanford California, 94305, United States
Local Institution - 975
Tampa Florida, 33612, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago Illinois, 60611, United States
Boston Children's Hospital
Boston Massachusetts, 02115, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Local Institution - 961
Detroit Michigan, 48201, United States
Weill Cornell Medical College
New York New York, 10065, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Local Institution - 967
Cleveland Ohio, 44195, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Local Institution - 972
Philadelphia Pennsylvania, 19104, United States
Vanderbilt - Ingram Cancer Center
Nashville Tennessee, 37232, United States
Vanderbilt - Ingram Cancer Center
Nashville Tennessee, 37232, United States
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Local Institution - 100
South Brisbane Queensland, 4101, Australia More Info
Site 100
Contact
Mater Hospital Brisbane
South Brisbane Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Monash Medical Centre
Clayton Victoria, 3168, Australia
Local Institution - 101
Camperdown , 2050, Australia More Info
Site 101
Contact
Royal Prince Alfred Hospital
Camperdown , 2050, Australia
Prince of Wales Hospital
Randwick , 2031, Australia
Algemeen Ziekenhuis Klina
Brasschaat , 2930, Belgium
Local Institution - 182
Brasschaat , 2930, Belgium
AZ Sint-Jan AV Brugge
Brugge , 8000, Belgium
Local Institution - 180
Brugge , 8000, Belgium
Local Institution - 183
Ghent , 9000, Belgium
Universitair Ziekenhuis Gent
Ghent , 9000, Belgium
Local Institution - 184
Leuven , 3000, Belgium
UZ Leuven
Leuven , 3000, Belgium
Local Institution - 220
Boulevard Sofia, 1797, Bulgaria More Info
Site 220
Contact
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv , 4002, Bulgaria
Specialized Hospital for Active Treatment of Haematological Diseases - Sofia
Sofia , 1756, Bulgaria
Multiprofile Hospital for Active Treatment Sveta Marina EAD
Varna , 9010, Bulgaria
Local Institution - 262
Toronto Ontario, M4N 3, Canada
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada
University Health Network
Toronto Ontario, M5G 2, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
CHU d'Angers
Angers , 49033, France
Local Institution - 305
Angers , 49033, France
Hopital Henri Mondor
Creteil , 94010, France
Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon
La Tronche , 38700, France
Local Institution - 310
La Tronche , 38700, France
CHRU de Lille-Hopital Claude Huriez
Lille , 59037, France
Local Institution - 306
Lille , 59037, France More Info
Site 306
Contact
Hopitaux de La Timone
Marseille Cedex 9 , 13385, France
Local Institution - 301
Marseille Cedex 9 , 13385, France
Hopital Saint Louis
Paris , 75010, France
Local Institution - 302
Paris , 75010, France More Info
Site 302
Contact
Hopital Haut Leveque
Pessac Cedex , 33604, France
Local Institution - 307
Pessac Cedex , 33604, France
Centre Hospitalier Lyon Sud
Pierre Benite cedex , 69495, France
Hopital civil
Strasbourg , 67091, France
Local Institution - 308
Strasbourg , 67091, France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse Cedex 9 , 31059, France
Local Institution - 309
Toulouse Cedex 9 , 31059, France
Hopital Bretonneau
Tours , 37044, France
Local Institution - 303
Tours , 37044, France
Medizinisches Versorgungszentrum (MVZ) Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin , 14195, Germany
Local Institution - 348
Dresden , 01307, Germany More Info
Site 348
Contact
Universitatsklinikum Carl Gustav Carus an der TU Dresden
Dresden , 01307, Germany
Universitaetsklinikum Duesseldorf
Duesseldorf , 40225, Germany
Local Institution - 346
Dusseldorf , 40479, Germany
Marien Hospital
Dusseldorf , 40479, Germany
Universitatsklinikum Halle Saale
Halle , 06120, Germany
Local Institution - 342
Hamburg , 22081, Germany More Info
Site 342
Contact
OncoResearch Lerchenfeld GmbH
Hamburg , 22081, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
Universitatsklinikum Leipzig
Leipzig , 04103, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz , 55131, Germany
Klinikum rechts der Isar der Technischen Universitaet Muenchen
München , 81675, Germany
Aghia Sophia' Children's General Hospital of Athens
Athens , 115 2, Greece
Laiko General Hospital of Athens - Center of Thalassemia
Athens , 115 2, Greece
Local Institution - 380
Athens , 115 2, Greece More Info
Site 380
Contact
Local Institution - 382
Athens , 115 2, Greece More Info
Site 382
Contact
General Hospital Georgios Gennimatas of Athens
Athens , 11527, Greece
University General Hospital of Patras
Rio Patras , 26500, Greece
General Hospital of Thessaloniki Hippokration
Thessaloniki , 54642, Greece
Local Institution - 381
Thessaloniki , 54642, Greece More Info
Site 381
Contact
HaEmek Medical Center
Afula , 18341, Israel
Local Institution - 425
Afula , 18341, Israel
Rambam Health Corporation
Haifa , 31096, Israel
Local Institution - 422
Jerusalem , 91031, Israel
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Galilee Medical Center
Nahariya , 22100, Israel
Rabin Medical Center
Petah Tikva , 49100, Israel
Local Institution - 471
Firenze Toscana, 50139, Italy More Info
Site 471
Contact
Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo
Allessandria , 15100, Italy
Local Institution - 470
Allessandria , 15100, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi
Bologna , 40138, Italy
Presidio Ospedaliero Antonio Perrino
Brindisi , 72100, Italy
Azienda Sanitaria Locale (ASL) Cagliari - Ospedale Regionale per le Microcitemie
Cagliari , 09121, Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
Ferrara , 44124, Italy
Azienda Ospedaliera Universitaria Careggi
Firenze , 50134, Italy
Azienda Ospedaliera Universitaria Careggi
Firenze , 50134, Italy
Ente Ospedaliero Ospedali Galliera - Centro della Microcitemia e delle Anemie Congenite
Genoa , 16128, Italy
Local Institution - 476
Genoa , 16128, Italy More Info
Site 476
Contact
Local Institution - 473
Lecce , 73100, Italy
Presidio Ospedaliero Vito Fazzi
Lecce , 73100, Italy
Local Institution - 467
Milano , 20122, Italy More Info
Site 467
Contact
Maggiore Polyclinic Hospital, IRCCS Ca' Granda
Milano , 20122, Italy
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena , 41100, Italy
Local Institution - 479
Modena , 41100, Italy
AORN A Cardarelli
Napoli , 80131, Italy
AOU dell'Università degli Studi della Campania Luigi Vanvitelli
Napoli , 80131, Italy
Local Institution - 461
Napoli , 80131, Italy More Info
Site 461
Contact
Local Institution - 475
Napoli , 80131, Italy More Info
Site 475
Contact
Azienda Ospedaliero Universitaria S. Luigi Gonzaga
Orbassano , 10043, Italy
Local Institution - 460
Orbassano , 10043, Italy More Info
Site 460
Contact
IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Di Calabria , 89124, Italy
Local Institution - 468
Reggio Di Calabria , 89124, Italy More Info
Site 468
Contact
Fondazione PTV Policlinico Tor Vergata
Roma , 133, Italy
Local Institution - 465
Roma , 133, Italy
Istituto Clinico Humanitas
Rozzano , 20089, Italy
Local Institution - 474
Rozzano , 20089, Italy
Local Institution - 472
Varese , 21100, Italy More Info
Site 472
Contact
Ospedale di Circolo di Varese
Varese , 21100, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona , 37134, Italy
Local Institution - 603
Sagamihara Kanagawa, 252-0, Japan More Info
Site 603
Contact
Local Institution - 0979
Sendai Miyagi, 980-8, Japan
Local Institution - 611
Nagasaki-shi Nagasaki, 852-8, Japan More Info
Site 611
Contact
Local Institution - 600
Shinagawa City Tokyo, 141-8, Japan More Info
Site 600
Contact
Local Institution - 500
Hazmieh , 00961, Lebanon More Info
Site 500
Contact
Chronic Care Center
Hazmieh , 1003, Lebanon
Hospital Sultanah Aminah
Johor Bahru Johor, 80100, Malaysia
Hospital Sultanah Bahiyah
Alor Setar Kedah, 05460, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh Perak, 30990, Malaysia
Local Institution - 543
Kota Kinabalu Sabah, 88586, Malaysia More Info
Site 543
Contact
Queen Elizabeth Hospital
Kota Kinabalu Sabah, 88586, Malaysia
Hospital Umum Sarawak
Kuching Sarawak, 93586, Malaysia
Local Institution - 544
Kuala Lumpur Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia More Info
Site 544
Contact
University Malaya Medical Centre
Kuala Lumpur Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam , 1081 , Netherlands
Hospital Universitario Cruces
Barakaldo , 48903, Spain
Local Institution - 681
Barakaldo , 48903, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Local Institution - 685
Barcelona , 08035, Spain
Instituto Catalan de Oncologia-Hospital Duran i Reynals
Barcelona , 08908, Spain
Local Institution - 686
Barcelona , 08908, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Local Institution - 687
Madrid , 28007, Spain
Hospital Universitario Central de Asturias
Oviedo , 33011, Spain
Local Institution - 682
Oviedo , 33011, Spain
Universitario de Salamanca - Hospital Clinico
Salamanca , 37007, Spain
Hospital Universitario Virgen del Rocio
Seville , 41013, Spain
Local Institution - 680
Seville , 41013, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia , 46026, Spain
Sahlgrenska Universitetssjukhuset
Goteborg , 413 4, Sweden
Local Institution - 722
Lund , SE-22, Sweden
Skanes Universitetssjukhus Lund
Lund , SE-22, Sweden
Karolinska Universitetssjukhuset - Huddinge
Stockholm , 141 8, Sweden
Local Institution - 721
Stockholm , 141 8, Sweden
Kaohsiung Medical University Hospital
Kaohsiung, San Ming Dist. , 807, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng Dist. , 10002, Taiwan
Chulalongkorn University Faculty of Medicine - King Chulalongkorn Memorial Hospital
Bangkok , 10330, Thailand
Local Institution - 802
Bangkok , 10700, Thailand More Info
Site 802
Contact
Siriraj Hospital Mahidol University
Bangkok , 10700, Thailand
Chiang Mai University - Maharaj Nakorn Chiang Mai Hospital
Chiang Mai , 50200, Thailand
University Hospital Farhat Hached
Sousse , 4031, Tunisia
Bone Marrow Transplant Center
Tunis , 1006, Tunisia
Aziza Othmana Hospital
Tunis , 1008, Tunisia
Military Hospital of Tunis
Tunis , 1008, Tunisia
Acibadem Adana Hospital
Adana , 01130, Turkey
Ankara University Medical Faculty Cebeci Hospital
Ankara , 06590, Turkey
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul , 34093, Turkey
Local Institution - 882
Istanbul , 34093, Turkey
Istanbul University Cerrahpasa Medical Faculty Hospital
Istanbul , 34098, Turkey
Ege Universitesi Tip Fakultesi Hastanesi
Izmir , 35100, Turkey
Mersin University Medical Faculty
Mersin , 33343, Turkey
Aberdeen Royal Infirmary
Aberdeen , AB25 , United Kingdom
Local Institution - 925
Aberdeen , AB25 , United Kingdom
Local Institution - 921
Leeds , LS9 7, United Kingdom
The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
Leeds , LS9 7, United Kingdom
Barts Health NHS Trust - The Royal London Hospital
London , E1 1B, United Kingdom
Local Institution - 923
London , E1 1B, United Kingdom
Whittington Hospital
London , N19 5, United Kingdom
Local Institution - 922
London , NW1 2, United Kingdom More Info
Site 922
Contact
University College London Hospitals NHS Foundation Trust - University College Hospital
London , NW1 2, United Kingdom
Local Institution - 928
London , SE1 9, United Kingdom More Info
Site 928
Contact
Kings College Hospital
London , SE5 9, United Kingdom
Local Institution - 929
Oxford , OX3 7, United Kingdom
Oxford University Hospitals NHS Foundation Trust-Churchill Hospital-Cancer and Haematology Centre
Oxford , OX3 7, United Kingdom
Kings Mill Hospital
Sutton in Ashfield , NG17 , United Kingdom
Local Institution - 926
Sutton in Ashfield , NG17 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

665

Study ID:

NCT04064060

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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